The Clinical Trials Research Office (CTRO) provides the infrastructure and facilitates the coordination necessary to support high quality clinical research in a matrix style cancer center. The science supported by the CTRO encompasses all levels and types of clinical trials, from pilot studies and phase I protocols through phase II and III protocols. These protocols may be UWCCC investigator-initiated institutional or industry sponsored clinical trials, or they may be NCI-sponsored clinical trials funded through the cooperative group, phase I, or research grant mechanisms. The CTRO infrastructure for clinical research supported by the CCSG grant is designed to facilitate and promote clinical research by providing effective mechanisms for quality control and efficiency. The UWCCC core component of the CTRO provides a basic level of protocol- specific support for all UWCCC clinical trials. This includes process coordination; protocol activation and closure; tracking by the UWCCC data base; regulatory review and compliance; patient registration and randomization; and quality assurance. The CTRO supports the Protocol Review and Monitoring System, providing checkpoints for quality control and for enforcement of the institutional authority to open and close protocols. It ensures complete reports on protocol activity and meaningful cancer center supervision of the cancer clinical research in the institution.